MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +6MM LATERAL OFFSET 40MM DIAMETER GLENOSPHERE; PROSTHESIS, SHOULDER

Catalog Number	110030778
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient has had a history of multiple revisions of their right reverse total shoulder that was initially implanted approximately 6 years ago.After receiving a new reverse shoulder approximately 2 months ago, the patient was revised again 1 month ago due to dislocation.The baseplate was retained and all other components were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4) d10: +3mm thickness 40mm diameter bearing cat# 110031422 lot# 64653541.H6: mechanical (g04) - head.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.The following section was corrected: a2.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided for this event.However, a patient timeline was reviewed by a health care professional.Review of the available records identified the following: on (b)(6) 2025: follow up: patient reported clicking and was found to have dislocated, no attempt at reduction offered.On (b)(6) 2025: er visit.Shoulder dislocated, unable to reduce in the er.On (b)(6) 2025: mayo clinic.Closed reduction performed.On (b)(6) 2025: follow up.Shoulder dislocated in the shower.On (b)(6) 2025: revision.¿open revision surgery on right shoulder.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: +6MM LATERAL OFFSET 40MM DIAMETER GLENOSPHERE
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21645213
• Report Number: 0001822565-2025-00671
• Device Sequence Number: 15434348
• Product Code: PHX
• UDI-Device Identifier: 00887868231278
• UDI-Public: (01)00887868231278(17)340418(10)66112197
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110030778
• Device Lot Number: 66112197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male